Audio Version: Over 140,000 Bottles of Cholesterol Medication Recalled
More than 140,000 bottles of a popular cholesterol-lowering medication have been recalled across the United States after the drug failed dissolution testing, according to the U.S. Food and Drug Administration (FDA).
The recall involves Atorvastatin Calcium, the generic version of Lipitor, manufactured by Alkem Laboratories in India and distributed by Ascend Laboratories in New Jersey.
The recall was officially announced on September 19, 2025, and affects tablets with expiration dates through February 2027.
FDA Classification
On October 10, 2025, the FDA classified the recall as a Class II recall, which means the medication could cause temporary or medically reversible health effects, though the risk of serious injury is considered low.
Statins, including atorvastatin, are among the most prescribed drugs in the U.S. They are used to lower cholesterol and reduce the risk of heart disease in millions of adults, especially those over the age of 40.
Recalled Atorvastatin Calcium Products
| Product Description | Bottle Size | Lot Numbers & Expiration Dates |
| Atorvastatin Calcium Tablets USP, 10 mg (NDC 67877-511-90 / -05 / -10) | 90-, 500-, 1,000-count | Lot#: 25141249 (Exp. Feb 2027), 24144938, 24144868, 24144867 (Exp. Nov 2026), 24144458, 24143994 (Exp. Sep 2026), 24142987, 24143316 (Exp. July 2026) |
| Atorvastatin Calcium Tablets USP, 20 mg (NDC 67877-512-90 / -05 / -10) | 90-, 500-, 1,000-count | Lot#: 25140150, 25140173, 25140172 (Exp. Dec 2026), 24144720, 24144798 (Exp. Nov 2026), 24144692 (Exp. Oct 2026), 24143755, 24143913, 24143754 (Exp. Aug 2026), 24143047 (Exp. June 2026), 24142936 (Exp. July 2026) |
| Atorvastatin Calcium Tablets USP, 40 mg (NDC 67877-513-90 / -05 / -10) | 90-, 500-, 1,000-count | Lot#: 25140933 (Exp. Feb 2027), 25140477 (Exp. Dec 2026), 24144254 (Exp. Oct 2026), 24144163, 24143995 (Exp. Sep 2026) |
| Atorvastatin Calcium Tablets USP, 80 mg (NDC 67877-514-90 / -05) | 90-, 500-count | Lot#: 25140249, 25140247 (Exp. Dec 2026), 24144999, 24144942, 24144845, 24144713 (Exp. Nov 2026), 24144652 (Exp. Oct 2026), 24143898, 24143412, 24143582 (Exp. Aug 2026) |
What Should Patients Do?
If you currently take Atorvastatin Calcium, follow these steps:
- Check your medication bottle for the NDC and lot numbers listed above.
- Contact your pharmacy to confirm if your batch is affected by the recall.
- Speak with your doctor before stopping or changing your medication.
- Dispose of recalled medication properly — your pharmacist can provide disposal instructions or locations.
Patients should not stop taking their statin medication abruptly without consulting a healthcare provider, as this may increase the risk of elevated cholesterol and cardiovascular events.
Why the Recall Happened
The recall was initiated after certain batches failed dissolution specifications, meaning the tablets might not dissolve properly in the body. This could potentially reduce the drug’s effectiveness in lowering cholesterol levels.
While the FDA categorized the recall as Class II, meaning no life-threatening danger is expected, the affected lots are being removed from circulation as a precaution.
Key Takeaways
- Over 140,000 bottles of Atorvastatin Calcium have been recalled.
- Recalled doses include 10 mg, 20 mg, 40 mg, and 80 mg tablets.
- The recall affects bottles with expiration dates between June 2026 and February 2027.
- Patients should check their lot numbers and consult their doctor or pharmacist for guidance.
